to: ad hoc organic regulatory committee i… · web viewvalid schedule 7.1 – organic product...

PROCESSOR/HANDLER INITIAL APPLICATION & CONTRACT

FOR ORGANIC CERTIFICATION

Some retailers/handlers may be exempt from all or part of the USDA-NOP.

FOR OFFICE USE ONLYReceived: / / Reg. #Retainer Fee: $_______________

This application is designed for certification to the Canadian Organic Regime (COR) including the National Standard of Canada (NSC) (Can/CGSB 32.310 & 32.311) and the Organic Products Regulation (OPR), the EEC Organic Regulation #834/07 & 889/08, the Quebec Organic Reference Standards and the USDA National Organic Program (NOP) . [If you wish to be certified to the USDA NOP only, request and complete Doc # 6.2.1-NOP.] This document is both an application and contract for certification services and record of your initial organic processing/handling system plan as required by the COR, the EEC and the NOP. Changes in your processing/handling plan will be recorded in an annual extension application and contract. If you are also involved in organic crop production request and complete Doc # 5.2.1 (or 5.2.1-NOP for NOP only). Before completion, make extra copies of the diagrams and attachments to this document. Save the original copies as “Masters” for future duplication. After completion, make a photocopy of the entire Application and Contract and retain in your file.

CERTIFICATION PROGRAMS

Please indicate which organic program you wish to be certified to:Canada Organic Regime (COR) Quebec Organic Food Control System (CARTV)USDA National Organic Program (NOP)* EU Reg. 834/07 & 889/08 (EU) 1

Other: (Specify): Japan Agricultural Standard (JAS)* Canadian Applicants Note: Access to the US and EU is gained via the COR/NOP and COR/EU Equivalency Arrangements respectively.

EXPORT & EQUIVALENCY AGREEMENTS

Please indicate which equivalency arrangements and export programs you wish to be certified to:COR/NOP COR/EU NOP/JAS NOP/EU Bio-SuisseCOR/Swiss COR/JAS Brazil

(IBD)Other (Specify):

1.0 APPLICANT INFORMATION [NSC .310, 4; NOP 205.201]

Applicant (Legal Entity): Year: Mailing Address: Plant Location(s): Phone No: ( ) Fax No: ( ) Email: Website: If a corporation, the authorized representative is: Phone No: ( ) Address:

1.1 Nature of Business

Generally describe the organic (and non-organic) food processing activities:

Valid Processor/Handler Initial Application Author: BJSH of 1006/26/15 Doc # 6.2.1 Reviewer: JWH, DL Version 8

Pro-Cert Organic Systems Ltd. © Pro-Cert 2015Head Office: Box 100A, RR 3 Saskatoon, SK S7K 3J6 Canada

Eastern Branch Office: 2311 Elm Tree Road, Box 74, Cambray, ON K0M 1E0 Canada

1.2 Organic Product Description

List the organic products, brand names and package sizes and type created in this facility and the approximate annual volume; indicate with an asterisk (*) any additions/deletions from the previous year:

Product Brand Name Size & Type Annual Volume

Any additions to the organic product/brand name line above constitute a change in the scope of certification and require partial or total re-evaluation.

1.3 External Regulation & Inspection

List and briefly describe the nature of Federal and Provincial (State) licenses and/or external inspection/accreditation (eg. ISO, HACCP, Kosher) programs in operation within the facility.

Agency Protocol Date of Last Inspection

1.4 Market Area:

List the countries into which you expect to export organic products:

2.0 ORGANIC CERTIFICATION HISTORY [NSC .310, 4.2; NOP 205.401(c)]




Describe the organic certification application and results for your facility under the following headings:

Certification BodyApplied to

CertificationApplication Year Application Results

Has organic certification ever been denied or withdrawn? Yes No

If Yes, state the reason and attach a copy of the notification of denial or withdrawal:

Were there any non-compliances identified in these certifications Yes No.If Yes, list the non-compliances and the corrective actions taken:

Non-compliance Corrective Action(s)

Attach copies of the Organic Certificate of Conformity, letter of transmittal and inspection report for the most recent certification event.

3.0 PROCESSING/HANDLING FACILITY DESCRIPTION [NOP 205.201]




For each of the geographically separate plant sites in your organic facility provide the following information:

3.1 Site Diagram(s):A reasonably accurate sketch of each site including (i) location and name of each building and improvement (ii) road and/or truck access (iii) adjacent property use.

3.2 Plant Diagram(s):An accurate representation of each plant component indicating the name and position of each machine/instrument.

3.3 Flow Diagram(s)A conceptual diagram of each product stream or group of streams within each plant.

3.4 Organic Dedication: [NSC .310, 8.3.10; NOP 205.272(a)]Is non-organic produce processed in this facility Yes No.

(i) If Yes, what is the nature of the non-organic processing activity:

(ii) Describe segregation of non-organic and organic products during handling, storage and transportation:

3.5 Contamination [NSC .310, 4.4.3; NOP 205.272]

Describe the procedures used to prevent contact of organic products with prohibited substances and sanitizing agents:

4.0 STANDARD OPERATING PROCEDURES [NSC .310, 4; NOP 205.201]




A copy of the SOP Manual must be available for inspector review.

When was the SOP Manual last revised?

If a SOP manual does not exist, what initiatives have been taken for creation of the same and what is the timetable for generation?

5.0 ORGANIC INGREDIENT CERTIFICATION RECORDS [NSC .310, 4.4.1; NOP 205.201(a)(2)]

A regularly updated Schedule of Supplier Certification Status (attached) including all organic ingredient suppliers and service providers must be maintained.

Is organic status of ingredients and service providers confirmed prior to receipt of organic products and/or services from the same? Yes No

Where current organic certificates have not been received for organic ingredient suppliers and service providers, describe procedures to protect the integrity of organic products and prevent co-mingling until certification status can be confirmed:

Do all suppliers bear appropriate certification status applicable to market area of the finished product? Yes No

6.0 PROCESSING PROCEDURES [NSC .310, 8.3; NOP 205.201(a)(1)]

Indicate the nature of the processing activities: cleaning grading cooking freezing baking curing drying mixing grinding churning separating distilling extracting slaughtering cutting fermenting packaging eviscerating jarring labeling other (specify):

Describe Transportation from ingredient supplier to the facility; include sanitation procedures:

Describe unloading and interim storage facilities and cleaning procedures:

Are there any substances added during interim storage? Yes No.If Yes, each substance must be included on the Input Substance Summary (attached).




Describe the conversion of the raw material(s) to finished product:

For each product or product group listed in Section 1.2, complete a copy of Schedule 7.1 – Organic Product Profile.

7.0 AUDIT TRAIL [NSC .310, 4.4.1; NOP 205.201(a)(4)]

Describe how you track products from the purchase and receipt of ingredients, through processing and finished product production to sales/distribution. Attach a flow diagram indicating all documents in the audit trail.

Are organic products assigned a lot/batch number that can be traced to the production event? Yes No

Describe the lot numbering system used:

Can finished product from the retail shelf be traced to original farm source and/or ingredient lots? Yes No

How frequently are physical inventory counts conducted? Annually Biennially Quarterly Monthly Weekly Daily Other:

When was the most recent physical inventory count completed?

8.0 PRODUCT LABELLING [OPR 21 to 25; NOP 205.303 to 310]




Do the individual finished product labels on the principle display panel and side panels conform with the country, province or state on which the products will be marketed? Yes No

Comments:

Attach copies of the principle and side panel labels for each product in the organic line to Schedule 7.1.Attach copies of the advertising material, scripts etc. to Schedule 7.1.

9.0 WATER QUALITY MONITORING

All chemical treatments and boiler additives applied to water in the facility must be listed on the Input Substance Summary (attached). Substances used in organic production must be approved by Pro-Cert prior to use.

Indicate the water source(s) for the facility(s): treated municipal untreated river, stream or lake treated well untreated well Other (Specify):

What treatment(s) physical or chemical are applied to water in the facility?

List known contaminants in water supplies in the area:

Indicate the nature of water use in the facility: Ingredient Food Contact Surfaces Non-Food Contact Surfaces Other:

How often is the water tested? daily weekly monthly other (specify):

Indicate the Laboratories used for analysis:

Are contracted laboratories ISO 17025 accredited? Yes NoIf No, please indicate the qualifications of the laboratory:

If steam is used in processing, indicate the frequency of testing for residues in steam condensate: N/A daily weekly after boiler cleaning Other (specify):

The water quality data file must be available for inspector review.10.0 COMPLAINTS AND CORRECTIVE ACTIONS [NSC .310, 4.2; ISO 65]




Describe procedures for handling complaints received regarding the quality of organic produce or products, including requirements for documenting and investigating the same. Indicate who is responsible for management of, and response to complaints :

Describe any complaints received regarding the quality of organic produce or products received in the last year:

Describe the corrective action(s) taken:

Have records available for review at the time of inspection.

11.0 SANITATION PRACTICES [NSC .310, 8.3; NOP 205.272]

All sanitation agents must be listed on the Input Substance Summary (attached). Substances used in organic production must be approved by Pro-Cert prior to use.

Indicate procedures taken to clean equipment: compressed air pressure washer brooms/brushes flushing vacuum rinsing clean in place (CIP) other (specify):

How frequently are facilities cleaned: daily weekly monthly yearly as required other (specify):

Describe cleaning and purging procedures between organic and non-organic runs:

A log of all sanitation activities must be maintained.

12.0 FACILITY PEST MANAGEMENT [NSC .310, 2.4; NOP 205.271]




All pest control substances must be listed on the Input Substance Summary (attached). Substances used in organic operations must be approved by Pro-Cert prior to use.

The pest management practices used in organic produce storage and handling buildings and facilities involve the following:

removal of pest habitat, food sources and breeding areasprevention of access to handling facilitiesmanagement of environmental factors, such as temperature, light, humidity, atmosphere and air circulation to prevent pest reproductionmechanical or physical controls including but not limited to traps, light or soundlures and repellents using non-synthetic or synthetic substances consistent with the lists of permitted substancesmechanical trapssound emitterslures (specify): repellent (specify): poison stations (specify): predators (specify): other (specify):

How often are the pest management devises monitored: daily weekly monthly yearly as required other (specify):

Monitoring events must be recorded in a Pest Control Log.

Attach a Pest Control Site Map indicating the location of all pest control devices and monitoring stations.

13.0 RECORD KEEPING SYSTEM [NSC .310, 4.4; NOP 205.103]

The following documents are used and maintained for at least five years to preserve product history and identity. Some are maintained and updated on a continuous basis, e.g. flow diagrams:

Site Diagram(s)Facility Diagram(s)Flow Diagram(s)Labels of all ingredients and substances used in the facility

Monitoring activities Equipment sanitation events Facility sanitation events Storage activities Product movement/shipping activities Pest management activities

Documentation of organic ingredients sources & certificatesa. Searches for commercially available organic ingredients

Schedule of Supplier Certification StatusIndependent Laboratory test results:

a. washing water quality




b. potable water qualityc. pesticide and transgenetic DNA analysis residue analysisd. ingredientse. raw materialsf. boiler water

Labor RecordsTransportation Sanitation AffidavitsSales RecordsVerification of Organic Status (VOS) Transaction Certificates (TC)Other (specify):

Has a 5 year record archive been established? Yes No

14.0 WASTE MANAGEMENT [NOP Additional Information]

Solid waste management:

Liquid waste management:

Gas waste management:

Describe Recycling Activities:

15.0 EMPLOYEE TRAINING [NSC .310, 4.1 Additional Information]

Describe your employee organic training procedures including seminars, staff meetings, etc. or give applicable SOP manual section reference.

16.0 CONTRACT FOR CERTIFICATION SERVICES




(a) It is hereby agreed that (hereinafter called the Applicant) retain Pro-Cert Organic Systems (Pro-Cert) for evaluation of conformity to the Canada Organic Regime, the USDA National Organic Program, the EEC Organic Regulation # 834/07 & 889/08, and the Quebec Organic Reference Standards and others as specified above for the estimated fee quoted and as outlined in the current Pro-Cert Fee Schedule. A retainer fee of $ is enclosed; the balance (remainder fee) will be paid upon receipt of an invoice but prior to application evaluation by Pro-Cert.

(b) It is further agreed that the Applicant will pay upon receipt of an invoice from Pro-Cert such additional costs incurred by Pro-Cert for surveillance during the certification period including but not limited to: (i) unannounced inspections, (ii) supplemental product inventory audits, (iii) additional forensic sample analyses and, (iv) surveillance actions. The rates and fees quoted in the current Pro-Cert Fee Schedule for processors are applicable.

(c) The Applicant hereby agrees to operate according to their Organic Production plan as described in this document and to inform Pro-Cert of any planned changes in its operating procedures and/or scope including but not limited to: (i) the type of produce grown on the operation, (ii) any processing conducted on the operation which could affect the organic conformity of the product prior to implementing such changes. Pro-Cert will determine if additional inspections are required. The applicant will not release product resulting from such changes without Pro-Cert approval.

(d) Pro-Cert, its employees and inspectors hereby agree to treat all information provided by the Applicant as obtained via inspection or research as confidential. Pro-Cert will obtain written permission from the applicant before disclosing confidential information. Pro-Cert is authorized to respond to legitimate inquiries as to the organic certification status of the applicant as may be received from time to time.

(e) The Applicant acknowledges that significant changes in procedures or scope of operation require an Application for Amendment of Certification and re-evaluation, the intensity of which is to be determined by Pro-Cert. Further, that failure to notify Pro-Cert can result in suspension or loss of certification status.

(f) The Applicant agrees to notify Pro-Cert in advance and at all times of the identity of any other company for which they intend to manufacture products under license, and thus as a result can use the Pro-Cert mark (name and logo) on the label of the product that it intends to market under its own brand name even though it does not hold a compliance certificate for those products.

(g) The Applicant hereby affirms and verifies that the description of the organic production unit and the procedures contained in this application are accurate and complete and he, she or it: (i) has read the applicable portion of the standards and/or regulation; (ii) will operate the facility in accordance with the standards or regulation during the certification period; (iii) will maintain accurate and current records of all organic (and non-organic) produce and products handled by the Applicant; (iv) will not misrepresent the certification status of the facility and its end products; (v) will not use its product certification in such a manner as to bring Pro-Cert into disrepute and not make any statement regarding its product certification which Pro-Cert may consider misleading or unauthorized; (vi) will use certification only to indicate that products are certified as being in conformity with specified organic standards; (vii) will endeavor to ensure that no certificate or report or any part thereof be used in a misleading manner.

(h) The Applicant hereby authorizes Pro-Cert to obtain and review any and all documents or information relevant to the evaluation including but not limited to: previous certification inspection reports and documents.

(i) The Applicant hereby authorizes and provides Pro-Cert, the Canada Organic Office (COO), Pro-Cert’s Conformity Verification Body (CVB) under the Canada Organic Regime (COR), the AMS Administrator, the applicable State Official, and CAEQ representatives access to premises, product, facilities, inventories, records and documents during normal business hours for the purpose of organic certification, audit, verification of compliance or analysis and copying and examination whether such access is arranged or unannounced.

(j) The Applicant hereby agrees to reproduce the Certificate of Conformity in it’s entirety when providing these documents to others.

(k) The applicant hereby agrees to maintain a record of all complaints made know to the Applicant relating to compliance with organic standards and regulations and to make these records available to Pro-Cert when requested. The Applicant further agrees to take appropriate action with respect to such complaints and any deficiencies found in products that affect compliance with organic standards and regulations and to document such actions.

(l) The Certificate of Conformity when issued and current entitles the applicant to display and use the term ‘organic’ and the Pro-Cert organic certification marks on produce and product labels and to use the same in advertising material provided that Pro-Cert first




reviews the wording of the said labels and materials. This license terminates with temporary or permanent withdrawal, suspension, revocation and/or cancellation of the Certificate of Conformity and/or upon lapse of the same. The Pro-Cert organic certification marks may appear on product labels while one of the following phrases must appear: (i) “Certified Organic by Pro-Cert Organic Systems”, (ii) “Certified Organic by Pro-Cert.”

(m) The Applicants hereby acknowledge that Pro-Cert has the right to suspend, cancel or revoke organic certification status when non-conformity with aforementioned standards and regulations is confirmed and that he, she or it agrees to terminate all reference to certification in the event of such action and further that Pro-Cert has the right to advertise such action as it sees fit. In the case of suspension, cancellation or revocation upon the date of notification of the same and during the specified period the Applicant will make no misleading claims as to the status of certification, and cease to use the certification mark and the term “organic” on the products concerned by the suspension, cancellation or revocation. In addition, Pro-Cert may require that no certified product be put up for sale and that non-conforming product be subject to a corrective action, including product recall and label correction.

(n) The applicant hereby agrees not to put up for sale any product bearing the word organic for which it has requested but not yet received certification

(o) The Applicant or Representative hereby also acknowledges that there are penalties for misrepresentation of product as organic and for the making of false statements to Pro-Cert.

(p) The Applicant hereby agrees to use of the English language in this and all other related documents.

For Office Use Only: Pro-Cert Organic Systems Ltd.Applicant (Legal Entity)

Signature of Applicant or Representative Signature & Title

Date Date

When completing this Application & Contract electronically, with your Retainer Fee please complete and submit an Electronic Signature Authorization (Doc # 5678 ESA) available on the Document Download page at www.pro-cert.org.

Return Application & Contract with Attachments and Retaining Fee to:

Pro-Cert Organic Systems Ltd.www.pro-cert.org

In Western North America:Head Office

Box 100A, RR 3, 475 Valley RoadSaskatoon, SK S7K 3J6

Phone: (306) 382-1299 Fax: (306) 382-0683Email: [email protected]

In Eastern North America:Eastern Branch Office

2311 Elm Tree Road, Box 74Cambray, ON K0M 1E0

Phone: (705) 374-5602 Fax: (705) 374-5604Email: [email protected]




http://www.pro-cert.org/

Input Substance Summary

Complete this table listing all inputs in use in the processing facility in the coming production year regardless of whether these are used for organic or non-organic production. You may exclude all non-organic ingredients from this list. The list must include all sanitation agents, pest control products, water treatments, boiler additives and processing aids to be applied in the facility. Attach a label and/or MSDS for all substances intended for use in organic production. This form is also available in an Excel Spreadsheet on our website www.pro-cert.org.

Note: All input substances used in organic processing may be subject to annotations regarding origin or use as detailed in the applicable standards/regulations. You may be required to submit addition information to demonstrate compliance with the same.

Applicant (Legal Entity):

Date Submitted:

Product Manufacturer Composition Use Organic1 Office UseOnly

Valid Input Substance Summary Author: BJSH Page 1 of 102/01/13 Doc # 4.2 Reviewer: JWH, DL Version 1

© Pro-Cert 2013


1 – Mark each product used in organic production; Leave substances used in non-organic production unmarked.

Valid Input Substance Summary Author: BJSH Page 1 of 102/01/13 Doc # 4.2 Reviewer: JWH, DL Version 1

© Pro-Cert 2013

Schedule of Supplier Certification Status

This form must be completed to include all external organic ingredient suppliers and/or custom service providers. This form is also available in an Excel Spreadsheet on our website www.pro-cert.org. Certification status of each entity must be verified on an annual basis via collection of current dated certification documentation. Copies of supplier certificates must be available at the time of inspection and on demand by Pro-Cert. All suppliers must bear certification appropriate for the jurisdiction and/or status the finished product is to be sold to (e.g. all suppliers for a product sold as NOP compliant must also bear a current NOP or NOP Equivalent certificate). For more information regarding equivalency of standards and regulations please see Pro-Cert’s Guide to Organic Equivalency.

Applicant (Legal Entity): Registration No.: Date Completed: / / Page of

Supplier Ingredient / Service Certification Body

Status Renewal Date

eg. Joe’s Farm Suppliers Wheat Flour, Whole Wheat Bran, Milled Oats Pro-Cert COR, COR/NOP 01/31/14

Valid Schedule of Supplier Certification Status Author: BJSH Page 1 of 101/15/13 Doc # 6.2.3 Reviewer: JWH, DL Version 2

© Pro-Cert 2013


Schedule 7.1Organic Product Profile

Applicant (Legal Entity): Date Submitted:

Product:

Packaging: Retail Wholesale Bulk Other:

Product Identity:

For all Retail packaged products provide the following (attach additional page as necessary)Brand Name(s) Package Size(s) Market Area(s)

Product Formulation:

Complete the table below, or attach additional pages as necessary.

Ingredient Supplier Organic(Y/N)

Quantity Units

Note: Ingredients with multiple constituents must be broken down to identify organic and non-organic ingredient composition. Current certification status for organic ingredient suppliers must be disclosed on the Schedule of Supplier Certification Status. Exclude water and salt in calculation of organic content.

Weight or Volume of Organic Ingredients (A)

Total Weight orVolume (B)

% Organic Content(A/B)*100

Valid Schedule 7.1 – Organic Product Profile Author: BJSH Page 1 of 201/15/13 Doc # 6.2.1 – 7.1 Reviewer: JWH, DL Version 8

Pro-Cert 2013

Non-Organic Agricultural Ingredients:

Has a search been conducted and documented showing each of the non-organic agricultural ingredients are not commercially available in organic form? Yes NoIf No, explain:

Note: The record of the search results for each non-organic ingredient must be available at the time of inspection.

Non-organic agricultural ingredients have been produced without1. Materials and products of genetic engineering (GMO’s)? Yes No2. Ionizing Radiation? Yes No3. Sewage Sludge? Yes No4. Cloned farm animals and their descendants (COR only)? Yes No

If Yes, attach supporting documentation provided by the manufacturer/supplier

Processing Aids:

Processing aids are considered substances that are added to a food for a technological effect during processing and are not present in the finished product or are present at insignificant and non-functional levels. Processing aids must be listed in the permitted substances list of the standards/regulations under which the food is being certified. Processing aids for products with the “100% Organic” claim (NOP Only) must be organic. Current certification status for organic processing aid suppliers must be disclosed on the Schedule of Supplier Certification Status.

Processing Aid Supplier Organic(Y/N)

Function

Has a search been conducted and documented showing processing aids of agricultural origin are not commercially available in organic form? Yes NoIf No, explain:

Note: The record of the search results for processing aids of agricultural origin must be available at the time of inspection.

Processing aids have been produced without1. Materials and products of genetic engineering (GMO’s)? Yes No2. Ionizing Radiation? Yes No3. Sewage Sludge? Yes No4. Nano-technology products or nano-processes? Yes No

If Yes, attach supporting documentation provided by the manufacturer/supplier

Product Labeling:

Attach a copy of all product labels applied to this product. Note: All labels referencing organic status in any fashion must be submitted to Pro-Cert for review and approval prior to printing. Label proofs are acceptable in pdf or jpg format.

For products sold in the:United States: N/A 100% Organic Organic Made with Organic…

Ingredient Statement only

Canada: N/A Organic X% Organic Ingredients Ingredient Statement only


Pro-Cert 2013

European Union: N/A Organic Ingredient Statement only

Japan: N/A Organic Ingredient Statement only


Pro-Cert 2013

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